PMID- 34767030 OWN - NLM STAT- MEDLINE DCOM- 20221118 LR - 20221118 IS - 1433-7347 (Electronic) IS - 0942-2056 (Linking) VI - 30 IP - 12 DP - 2022 Dec TI - Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial. PG - 3958-3967 LID - 10.1007/s00167-021-06793-4 [doi] AB - PURPOSE: The purpose of this double-blind randomized controlled trial (RCT) was to compare clinical improvement and radiographic findings up to 2 years of follow-up of a single intra-articular injection of bone marrow aspirate concentrate (BMAC) versus hyaluronic acid (HA) for the treatment of knee osteoarthritis (OA). The hypothesis was that BMAC injection could lead to better clinical and radiographic results compared to viscosupplementation. METHODS: Patients with bilateral knee OA were randomized to one intra-articular injection of tibial-derived BMAC in one knee and one HA injection in the contralateral knee. Sixty patients were enrolled, and 56 were studied up to the final follow-up (35 men, 21 women, mean age 57.8 +/- 8.9 years), for a total of 112 knees. Patients were evaluated before the injection and at 1, 3, 6, 12, and 24 months with the IKDC subjective score, VAS for pain, and the KOOS score. Minimal clinically important difference (MCID), patient treatment judgement, and adverse events were documented, as well as bilateral X-Rays (Rosenberg view) before and after treatment. RESULTS: No severe adverse events nor differences were reported in terms of mild adverse events (7.1% vs 5.4%, p = ns) and treatment failures (10.7% vs 12.5%, p = ns) in BMAC and HA groups, respectively. The IKDC subjective score improved from baseline to all follow-ups for BMAC (p < 0.0005), while it improved up to 12 months (p < 0.0005) and then decreased at 24 months (p = 0.030) for HA. Compared to HA, BMAC showed a higher improvement for VAS pain at 12 (2.2 +/- 2.6 vs 1.7 +/- 2.5, p = 0.041) and 24 months (2.2 +/- 2.6 vs 1.4 +/- 2.8, p = 0.002). The analysis based on OA severity confirmed this difference only in Kellgren-Lawrence 1-2 knees, while comparable results were observed in moderate/severe OA. Radiographic evaluation did not show knee OA deterioration for both treatment groups, without intergroup differences. CONCLUSION: BMAC did not demonstrate a clinically significant superiority at short-term compared to viscosupplementation, reporting overall comparable results in terms of clinical scores, failures, adverse events, radiographic evaluation, MCID achievement, and patient treatment judgment. However, while HA results decreased over time, BMAC presented more durable results in mild OA knees. LEVEL OF EVIDENCE: Level I. CI - (c) 2021. The Author(s) under exclusive licence to European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA). FAU - Boffa, Angelo AU - Boffa A AD - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy. FAU - Di Martino, Alessandro AU - Di Martino A AD - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy. FAU - Andriolo, Luca AU - Andriolo L AD - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy. FAU - De Filippis, Roberto AU - De Filippis R AD - Clinica Mediterranea, Via Orazio 2, 80122, Napoli, Italy. FAU - Poggi, Alberto AU - Poggi A AUID- ORCID: 0000-0003-3569-7672 AD - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy. poggialberto8@gmail.com. FAU - Kon, Elizaveta AU - Kon E AD - Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, 20089, Rozzano, MI, Italy. AD - Humanitas University, Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, MI, Italy. AD - Department of Traumatology, Orthopedics and Disaster Surgery, Sechenov First Moscow State Medical University (Sechenov University), 2-4 Bolshaya Pirogovskaya st., 119991, Moscow, Russia. FAU - Zaffagnini, Stefano AU - Zaffagnini S AD - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Via Di Barbiano, 1/10, 40136, Bologna, Italy. FAU - Filardo, Giuseppe AU - Filardo G AD - Applied and Translational Research (ATR) Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20211112 PL - Germany TA - Knee Surg Sports Traumatol Arthrosc JT - Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA JID - 9314730 RN - 9004-61-9 (Hyaluronic Acid) SB - IM MH - Male MH - Female MH - Humans MH - Middle Aged MH - Aged MH - *Viscosupplementation/methods MH - *Osteoarthritis, Knee/drug therapy MH - Follow-Up Studies MH - Bone Marrow MH - Treatment Outcome MH - Injections, Intra-Articular MH - Hyaluronic Acid/therapeutic use MH - Pain/drug therapy OTO - NOTNLM OT - BMAC OT - Bone marrow OT - Hyaluronic acid OT - Injection OT - Knee OT - MSCs OT - Osteoarthritis EDAT- 2021/11/13 06:00 MHDA- 2022/11/19 06:00 CRDT- 2021/11/12 12:19 PHST- 2021/08/09 00:00 [received] PHST- 2021/10/25 00:00 [accepted] PHST- 2021/11/13 06:00 [pubmed] PHST- 2022/11/19 06:00 [medline] PHST- 2021/11/12 12:19 [entrez] AID - 10.1007/s00167-021-06793-4 [pii] AID - 10.1007/s00167-021-06793-4 [doi] PST - ppublish SO - Knee Surg Sports Traumatol Arthrosc. 2022 Dec;30(12):3958-3967. doi: 10.1007/s00167-021-06793-4. Epub 2021 Nov 12.